Atlas FDA

2022

3,209 FDA 510(k) clearances · Clearance year

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RecordFirmDate
TE Air Diagnostic Ultrasound System (K220051)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2022-03-04
Medcare Powder-Free Blue Nitrile Patient Examination Gloves (K211808)Dongguan Grinvald Technology Co., Ltd.2022-03-04
Skanmobile, Skanmobile-Dr (K212940)Skanray Technologies Limited2022-03-04
BTL-995-rTMS (K212723)BTL Industries, Inc.2022-03-04
Surgical Gown (K213703)Wujiang Tutaike Textiles & Finishing Co., Ltd.2022-03-04
geko W-3 (K220327)Firstkind Limited2022-03-04
Disposable Automatically Retractable Insulin Safety Syringe (K210216)Shantou Wealy Medical Instrument Co.,Ltd2022-03-04
Flexible Block (K213994)Shandong Huge Dental Material Corporation2022-03-04
Powder Free Black Nitrile Examination Gloves, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Resistant (K210330)Wrp Asia Pacific Sdn. Bhd.2022-03-04
Patient Information Center iX (K211900)Philips Medizin Systeme Böblingen GmbH2022-03-04
KISS Dynamic Back Support, KISS Dynamic Solid Drop Seat (K211919)Kinetic Innovative Seating System, LLC2022-03-04
PolyLock Plating System (K211843)Fusion Orthopedics2022-03-04
Surgical Mask (K213358)Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd.2022-03-04
Second Opinion (K210365)Pearl, Inc.2022-03-04
Exactech® Equinoxe® Laser Cage Glenoid (K212356)Exactech, Inc.2022-03-04
Surgical Trays (K212281)Dentsply Sirona, Inc.2022-03-04
OR Head Holder LUCY with HeadCoilSet Siemens 1.5T, OR Head Holder LUCY with HeadCoilSet Siemens 3T, OR Head Holder LUCY with HeadCoilSet Philips 1.5T, OR Head Holder LUCY with HeadCoilSet Philips 3T (K211658)Noras Mri Products GmbH2022-03-03
MyndMove 2.0 (K212149)Myndtec, Inc.2022-03-03
Disposable Endoscopic Staplers and Reload Unit, Disposable Hemorrhoidal Cutter Staplers, Disposable Linear Cutter Staplers, Disposable Circular Staplers (K211811)Wuxi Beien Surgery Device Co., Ltd.2022-03-03
nordicDSC (K212720)Nordicneurolab AS2022-03-03
IMPEACE and IMPEACE-Uni Anterior Cervical Plate System (K220379)Medynus, Inc.2022-03-03
IV Administration Set (K213778)B.Braun Medical, Inc.2022-03-03
easy Claire (K213285)Y & J Bio Co., Ltd.2022-03-03
TENS & EMS Device (K213835)Shenzhen Jian Feng Electronic Technology Co., Ltd.2022-03-03
Hemoclip (K211787)Hangzhou AGS MedTech Co., Ltd.2022-03-03
Astroglide Sensual Strawberry Personal Lubricant (K213671)Biofilm, Inc.2022-03-03
Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Elition and MR 7700 with Distributed Multi Nudclei (K213516)Philips Medical Systems Nederland B.V.2022-03-03
Osteon Precision Milled Suprastructure (K212676)Implant Solutions Pty Ltd (Osteon Medical)2022-03-03
MR Elastography; MZEK-001A (K220018)Canon Medical Systems Corporation2022-03-03
Air Compression Leg Massager (model: FE-7204B) (K211850)Xiamen Healthpal Electronic Co.,Ltd2022-03-03
Fort Defiance Industries FRONT-LINE Field Sterilizer FL120, Fort Defiance Industries FRONT-LINE Field Sterilizer FL135 (K213457)Fort Defiance Industries, LLC2022-03-02
A-dec 300, A-dec 500 (K213932)A-Dec, Inc.2022-03-02
Giraffe Omnibed Carestation CS1 (K213551)Datex Ohmeda, Inc.2022-03-02
Sterile Syringe with Fixed Safety Needle for Single Use (K212652)Gemtier Medical (Shanghai), Inc.2022-03-02
ReNew Disposable Scissor Tips (K213127)Microline Surgical, Inc.2022-03-02
Southern Implants Instrument Trays (K210923)Southern Implants (Pty), Ltd.2022-03-02
ASTM Level 1/EN14683 Type IIR 3-Ply disposable Surgical Mask, Model number: FM-1400G (K203376)Medtecs (Taiwan) Corp.2022-03-02
NovaGuide 2 Intelligent Ultrasound (K213279)Novasignal Corporation2022-03-02
Medline UNITE Calcaneal Fracture Plating System (K213567)Medline Industries, LP2022-03-02
Dental Image Plate Scanner, Model DFC-4T-SMART (K214091)Hefei Dentafilm Medical Equipment Co., Ltd.2022-03-02
Plasma Edge resection and vaporization electrodes, Plasma Edge working elements, Adaptor Plasma Edge (K213135)Chirurgie Innovation2022-03-02
angioLOCK Polymer Ligating Clip (K220006)A2 Medical Systems, LLC2022-03-02
N Latex FLC kappa, N Latex FLC lambda (K212379)Siemens Healthcare Diagnostics Products GmbH2022-03-02
Bio Fluff System (K201861)Gnali Bocia S.R.L.2022-03-02
Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D and Stellaris 3D Ceph (K213579)Fona S.R.L2022-03-02
Sugita AVM Microclips (K211183)Mizuho America, Inc.2022-03-02
Giraffe Incubator Carestation CS1 (K213553)Datex Ohmeda, Inc.2022-03-02
Plus Medical Isolation Gown Level 3 (K212698)Foshan Nanhai Plus Medical Co, Ltd.2022-03-02
LOTA SLA Dental Implant System and LOTA HA Dental Implant System (K202046)Kj Meditech Co., Ltd.2022-03-01
Disposable Sterile Syringe with Safety Needle; Disposable Sterile Syringe with Needle; Disposable Sterile Syringe; Disposable Safety Needles (K211484)Shinva Ande Healthcare Apparatus Co., Ltd.2022-03-01
Sure-Fine Insulin Syringes (K210848)Shina Med Corporation2022-03-01
Microlife Non-Contact Infrared Forehead Thermometer, Model FR1MF1-B (NC150 BT) (K211776)Microlife Intellectual Property GmbH2022-03-01
Restoration® Modular Hip System (K212187)Howmedica Osteonics Corp., Dba Stryker Orthopaedics2022-03-01
BoneView (K212365)Gleamer2022-03-01
Agilia SP Infusion System, Agilia SP MC WIFI Infusion Pump, Agilia Link, Agilia Duo, Agilia USB Cable (K210074)Fresenius Kabi AG2022-03-01
Wrist-type Fully Automatic Digital Blood Pressure Monitor (K213189)Joytech Healthcare Co. , Ltd.2022-03-01
GoBack Crossing Catheter (K211802)Upstream Peripheral Technologies, Ltd.2022-03-01
Grosz Play Aloe, Grosz Play Ylang, Grosz Play Guarana, Grosz Play Cherry, Grosz Play Strawberry (K213400)Rb Health (Us)2022-03-01
Sterile Disposable Temperature Probe (K212945)Shenzhen Envisen Industry Co., Ltd.2022-03-01
Blue Topaz Sacroiliac Screw System (K213590)Osseus Fusion Systems, LLC2022-03-01
Vigilant Software Suite – Vigilant Master Med (K210075)Fresenius Kabi AG2022-03-01
Sterile Latex Surgical Gloves Powder Free (K212596)Amazing Rubber Products Pvt, Ltd.2022-03-01
Dynamyx Digital Pathology Software (K210811)Inspirata, Inc.2022-03-01
Agilia VP Infusion System, Agilia VP MC WIFI Infusion Pump, Volumat Lines Administration Sets, Agilia Link, Agilia Duo (K210073)Fresenius Kabi AG2022-03-01
DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectomy System, Exchangeable Series, Stealth 360 Peripheral Orbital Atherectomy System (K220109)Cardiovascular Systems, Inc.2022-03-01
Digimamo D (K210151)Vmi Tecnologias Ltda2022-03-01
Endoluminal Occlusion System, EOS-X, Endoluminal Occlusion System, EOS (K212057)Artventive Medical Group, Inc.2022-03-01
MYAH (K211868)Visia Imaging S.R.L.2022-03-01
Disposable Nitrile Examination Gloves (K212833)Chifeng Huawei Medical Science&Technology Co., Ltd.2022-02-28
VyLink™ Spinal Screw System (K213750)Vy Spine, LLC2022-02-28
ENFit enteral syringes (NUTRIFIT) (K211661)Pentaferte Italia S.R.L.2022-02-28
Vathin Video Bronchoscope System (K213635)Hunan Vathin Medical Instrument Co., Ltd.2022-02-28
CardioChek Plus Test System; CardioChek Plus Home Test System (K193406)Polymer Technology Systems, Inc. D/B/A Pts Diagnostics2022-02-26
Laser treatment system , models Nyx plus, Grace plus, Nemesis, Ares (K211722)Canadian Pioneer Medical Technology Corporation2022-02-25
Ear Thermometer, Model ET005, ET008, ET009 (K213084)Guangzhou Berrcom Medical Device Co., Ltd.2022-02-25
Explorer Air II (K214097)Surgvision GmbH2022-02-25
OmniTom Elite (K211711)Neurologica Corporation, A Subsidiary of Samsung Electronics2022-02-25
Okamoto 002 Lubricated Polyurethane Male Condom (K203541)Okamoto USA, Inc.2022-02-25
MAGNETOM Vida with syngo MR XA50A (K213693)Siemens Medical Solutions USA, Inc.2022-02-25
VITEK 2 AST-Yeast Fluconazole (<=0.5->=64 µg/mL), VITEK 2 AST-YS Fluconazole (<=0.5->=64 µg/mL), VITEK 2 AST-YS Fluconazole (K213241)bioMerieux, Inc.2022-02-25
Normatec 3 (K220217)NormaTec Industries, LP2022-02-25
Ion Facet Screw System (K211855)SurGenTec, LLC2022-02-25
Cool-tip RF Ablation System E Series (K203150)Covidien, LLC2022-02-25
PRIMA Humeral System and SMR Glenosphere Ø42 (K212800)Lima Corporate S.P.A.2022-02-25
FEops HEARTguide (K214066)Feops NV2022-02-25
Levator Elite (Model LE9011) (K213043)Shenzhen Dongdixin Technology Co., Ltd.2022-02-25
Masimo SedLine Sedation Monitor and Accessories (K203113)Masimo Corporation2022-02-25
Pulse Oximeter (K212300)Shenzhen Mericonn Technology Co., Ltd.2022-02-25
Cohitech Cottonlock Tampons with Reusable Applicator (K220238)Cotton High Tech S.L.2022-02-25
uLab Systems Dental Aligner Kit (K211510)Ulab Systems, Inc.2022-02-24
Epione (K211645)Quantum Surgical Sas2022-02-24
NightOwl (K220028)Ectosense NV2022-02-24
ArtiSential Laparoscopic Instruments-Electrodes (K220384)Livsmed, Inc.2022-02-24
Cleaner Plus Thrombectomy System (K211798)Argon Medical Devices, Inc.2022-02-24
PROMOGRAN PRISMA Matrix, Small Dressing, PROMOGRAN PRISMA Matrix, Large Dressing (K210135)3M Healthcare Business Group2022-02-24
Bodygard SFS Surgical Gown Level 3 (K202845)Feliks Plastik Laminasyon VE Ambalaj Malzemeleri Sanayi2022-02-24
CAPRI Corpectomy Cage System (K211320)K2m, Inc.2022-02-24
Luminice (K214100)Premier North America, Inc.2022-02-24
Sterile Syringe with Safety Needle for Single Use, Sterile Syringe with Needle for Single Use, Sterile Syringe for Single Use, Sterile Safety Needle for Single Use, Sterile Needle for Single Use (K212949)Henan Nursecare Biotechnology Co., Ltd.2022-02-24
ROKI Surgical Mask (K214094)Roki Co., Ltd.2022-02-24
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Every clearance here is in the API, with alerts when new ones post.